Photobiomodulation in Dry Age Related Macular Degeneration

Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Study ID
NCT06046118
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) — DEVICE
    Each session consists of: * 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened) * 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened). Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).
  • Sham Mask — DEVICE
    Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)

Study Details

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: * Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? * Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: * 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; * 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

Key Dates

First listed
Sep 21, 2023
Start date
Apr 1, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).
  • Sham Comparator: Sham group
    Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).

Primary Outcome Measure

Best Corrected Visual Acuity variation [ Time Frame: 1 month, 2 months and 4 months after each cycle ]

Central Contacts

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